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CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) — CLEVER  

Liver Metastases Clinical Trial

Official title:
An Open-Label Phase 1b Clinical Study of Intravenous CAVATAK® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)

Clinical Trial Summary

This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.

Clinical Trial Description

This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver. Subjects will receive up to 8 cycles of CVA21 at a planned dose of 1 x 10e9 TCID50 per infusion, with the first cycle being a 28-day cycle consisting of an intravenous infusion on Days 1, 3, 5 and 8 and subsequent cycles every 21 days from Day 8. Ipilimumab will be given by intravenous administration at a dose of 3mg/kg, for a maximum of 4 doses, given on Days 8, 29, 50 and 71. On days when both CVA21 and ipilimumab are given, CVA21 will be given first. Subjects will be monitored for treatment toxicity using the current version of CTCAE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03408587
Study type Interventional
Source Viralytics
Contact
Status Completed
Phase Phase 1
Start date January 29, 2018
Completion date May 22, 2019
View Details
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